Reprieve Completes Enrollment in FASTR Pilot Trial

October 7, 2024—Reprieve Cardiovascular, Inc., announced the completion of enrollment in the FASTR trial assessing the safety and efficacy of the company’s intelligent, automated diuretic, and fluid management approach for acute decompensated heart failure (ADHF) treatment.

According to the company, the FASTR trial aims to compare the effectiveness of decongestive therapy administered by the Reprieve system with optimal diuretic therapy (ODT) in patients diagnosed with ADHF. The study's primary objective is to determine whether the Reprieve system can more efficiently decongest ADHF patients compared to standard-of-care therapy.

The trial enrolled 100 patients who were randomized into two groups. The experimental group received personalized treatment using the Reprieve system. The active comparator group received ODT.

The company stated that the primary efficacy endpoint of the study is the total urine sodium output at 24 hours posttreatment initiation. The primary safety endpoint includes clinically significant acute kidney injury, symptomatic hypotension, or hypertensive emergency. Secondary outcomes will assess the net fluid removal during treatment, heart failure rehospitalization, and the total time on loop diuretics.

James Udelson, MD, Chief of Cardiology at Tufts Medical Center in Boston, Massachusetts, is the principal investigator of the FASTR trial.

“For decades, managing fluid removal in patients with ADHF has presented a significant challenge, with many failed trials of new drugs or devices,” commented Dr. Udelson in Reprieve’s press release. “Diuretics, which have been the only widely used therapeutic option, are difficult to administer precisely without real-time information on patient response, making it challenging to balance rapid fluid removal with the risk of kidney injury, and thus are rarely used optimally. In addition, these patients are often faced with lengthy hospital stays, incomplete decongestion at discharge, and frequent readmissions due to fluid volume overload.”

He continued, “The Reprieve system is a promising heart failure management solution that can be easily implemented into existing clinical workflows, while also elevating the current level of care. As a result, this may help ease the workload burden for clinicians treating heart failure patients.”

The company noted that the Reprieve system is intended to personalize decongestion management and safely, quickly, and completely remove excess fluid to improve patient outcomes and prevent hospital readmissions. The device works with the kidneys to remove fluid through precise administration of diuretics, rapidly finding the optimal dose while ensuring they receive an adequate amount of sodium to support optimal kidney function.